Datex-Ohmeda F-LM1 Product manual

Datex-Ohmeda
S/5TM Light Monitor, F-LM1, F-LMP1
Technical Reference Manual
All specifications are subject to change without notice.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.
Outside the USA, check local laws for any restriction that may apply.
Order Code M1037863
October 2005
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison, WI 53707-7550, USA
Tel. [phone]
Fax [phone]
Healthcare Finland Oy
Helsinki, Finland
P.O. Box 900
FIN-00031 GE, FINLAND
Tel: [phone]
Fax : [phone]
www.datex-ohmeda.com www.gehealthcare.com
©2005 Copyright General Electric Company

Intended purpose
Datex-Ohmeda S/5 Light Monitor, F-LM1, F-LMP1 is intended for stationary and mobile monitoring of
patient’s ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration
and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case. The
monitor is intended for use by qualified medical personnel only. The S/5 Light Monitor is intended for
patients with weight from 5 kg (11 lb.) up. Respiration monitoring is intended for patients three years old and
up.
Classification according to IEC 60601-1
• CLASS I EQUIPMENT and INTERNALLY POWERED EQUIPMENT according to the type of protection against
electrical shock.
• TYPE BF or CF equipment according to the degree of protection against electric shock is indicated with a
symbol beside each patient connector.
• Degree of protection against harmful ingress of water as detailed in the IEC 60529: Monitor: IPX1,
vertically falling water drops shall have no harmful effects (applicable when the monitor is in upright
position, or tilted backwards). In the protective case IPX4, splash proof, when the case is closed
properly, the monitor is intact and operates on battery power. Power adapter: IPX0, ordinary equipment.
• EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE with air or with
oxygen or nitrous oxide.
• CONTINUOUS OPERATION according to the mode of operation.
• CSPR 11: Group 1, Class A
Classification according to EU Medical Device Directive
• The monitor is classified as IIb.
Responsibility of the manufacturer
GE Healthcare Finland Oy (GE) is responsible for the safety, reliability and performance of the equipment only
if:
• assembly, operations, extensions, readjustments, modifications, service and repairs are carried out by
authorized personnel.
• the electrical installation of the relevant room complies with appropriate requirements.
• the equipment is used in accordance with the User’s Reference Manual and serviced and maintained in
accordance with the Technical Reference Manual.
The CO2measuring option (N-LCM) is manufactured for GE Healthcare Finland Oy by
Welch Allyn OEM Technologies, 8500 SW Creekside Place, Beaverton, OR 97008 USA.
Trademarks
Trademarks Datex, Ohmeda, S/5, MemCard, ComWheel and Oxytip+ are property of GE Healthcare Finland
Oy. All other product and company names are property of their respective owners.

Master table of contents
Datex-Ohmeda S/5TM Light Monitor
Technical Reference Manual, M1037863
PART I, General Service Guide
Document
No.
Updated Updated Description
M1051339 Introduction, Safety, Architecture, Functional check, Service check, General
troubleshooting, Service Menu, General specifications
1
8001934-2 Planned Maintenance Instructions 2
PART II, Product Service Guide
M1051339 CPU 1
8000060-1 Power Supply Unit 2
8000060-1 Hemodynamic Unit 3
8000060-1 CO2Unit 4
8000060-1 Isolation Power Supply Unit for CO2Unit 5
890201-5 Datex-Ohmeda Light Monitor Recorder, N-LREC 6
M1051340 Datex-Ohmeda Light Monitor Power Adapter, N-LPOW 7
890200-5 Datex-Ohmeda Light Monitor Battery Module, F-LBAT 8
896192-1 Datex-Ohmeda Light External Battery Charger, N-LCHGR 9
8000060-1 DataCard and Network Options, N-LDATA, N-LNET, N-LDNET 10
M1051358 Spare Parts, Upgrade Kits and Exploded Views 11
896551-2 Optional N-LCM Upgrade for Light Monitor 12
896552-2 Optional N-LDNET Upgrade for Light Monitor
896553-2 Optional N-LDATA Upgrade for Light Monitor
896554-2 Optional N-LNET Upgrade for Light Monitor
- Method of Replacing the Lamp Unit (LCD Backlight)
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Table of contents
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TABLE OF CONTENTS
PART 1 - GENERAL SERVICE GUIDE
TABLE OF CONTENTS i
Part 1 - General Service Guide i
TABLE OF FIGURES iii
1INTRODUCTION 1
1.1 Notes to the reader............................................................................................................................... 2
1.2 About this manual................................................................................................................................ 2
1.3 Related documents .............................................................................................................................. 2
1.4 Installation .......................................................................................................................................... 3
1.4.1 Choosing the location .................................................................................................................. 3
1.4.2 Warnings ..................................................................................................................................... 3
1.5 Symbols .............................................................................................................................................. 4
1.5.1 Symbols on equipment ................................................................................................................ 4
1.5.2 Symbols on transport packaging................................................................................................... 6
2SAFETY 8
2.1 Safety precautions ............................................................................................................................... 8
2.1.1 Warnings ..................................................................................................................................... 8
2.1.2 Cautions.................................................................................................................................... 11
2.2 ESD precautionary procedures............................................................................................................ 12
2.3 Safety test ......................................................................................................................................... 13
3ARCHITECTURE 14
3.1 Monitor structure................................................................................................................................ 14
3.2 Power supply unit............................................................................................................................... 16
3.3 CPU................................................................................................................................................... 16
3.4 NIBP unit ........................................................................................................................................... 17
3.5 ECG unit ............................................................................................................................................ 17
3.6 STP unit ............................................................................................................................................. 17
3.7 CO2unit............................................................................................................................................. 17
3.8 Display unit........................................................................................................................................ 18
3.8.1 Slave display ............................................................................................................................. 18
3.9 Power adapters.................................................................................................................................. 18
3.9.1 N-LPOW..................................................................................................................................... 18
3.10 Host serial communications ........................................................................................................... 18
3.10.1 Module bus ........................................................................................................................... 18
3.10.2 Computer interface (RS-232) ................................................................................................. 18
3.10.3 CO2module........................................................................................................................... 19
3.10.4 Power board .......................................................................................................................... 19
3.10.5 Recorder ............................................................................................................................... 19
4CLEANING 20
5FUNCTIONAL CHECK 21
5.1 General functional inspection ............................................................................................................. 21
5.1.1 Recorder test ............................................................................................................................. 23
5.1.2 PCMCIA card test ....................................................................................................................... 23
5.1.3 Network test .............................................................................................................................. 24

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5.1.4 ECG board tests......................................................................................................................... 25
5.1.5 STP board tests ......................................................................................................................... 25
5.1.6 NIBP board test ......................................................................................................................... 26
5.1.7 Mainstream CO2test.................................................................................................................. 26
5.2 Performance checks........................................................................................................................... 27
6SERVICE CHECK 30
6.1 General service information................................................................................................................ 30
6.2 Service check procedure .................................................................................................................... 30
6.2.1 Visual inspection ....................................................................................................................... 31
6.2.2 Recorder test............................................................................................................................. 35
6.2.3 PCMCIA card test....................................................................................................................... 35
6.2.4 Network test .............................................................................................................................. 35
6.2.5 ECG measurement..................................................................................................................... 36
6.2.6 Respiration measurement.......................................................................................................... 37
6.2.7 Temperature measurement ........................................................................................................ 39
6.2.8 Invasive blood pressure measurement........................................................................................ 39
6.2.9 SpO2measurement ................................................................................................................... 40
6.2.10 Non Invasive Blood Pressure measurement ............................................................................ 41
6.2.11 Mainstream CO2measurement .............................................................................................. 43
6.2.12 For Light Monitor.................................................................................................................... 44
7ADJUSTMENTS AND CALIBRATIONS 45
7.1 Pressure safety level detection “OFFSET”............................................................................................. 45
7.2 NIBP calibrations ............................................................................................................................... 45
7.2.1 Calibration check....................................................................................................................... 45
7.2.2 Calibration ................................................................................................................................ 46
7.3 Temperature calibration ..................................................................................................................... 47
7.4 Invasive pressure calibration .............................................................................................................. 48
8GENERAL TROUBLESHOOTING 49
8.1 Troubleshooting flowchart .................................................................................................................. 49
9SERVICE MENU 50
9.1 SW version / unit ID ........................................................................................................................... 50
9.2 Language selection ............................................................................................................................ 51
9.3 Monitor configuration......................................................................................................................... 51
10 GENERAL SPECIFICATIONS 52
10.1 Parameter specifications................................................................................................................ 52
10.1.1 ECG ...................................................................................................................................... 52
10.1.2 Impedance respiration...........................................................................................................52
10.1.3 Pulse oximetry (SpO2)/Pleth.................................................................................................. 53
10.1.4 Temperature.......................................................................................................................... 53
10.1.5 Non-invasive blood pressure.................................................................................................. 54
10.1.6 Invasive blood pressure (LMP1 models only)........................................................................... 54
10.1.7 CO2(option N-LCM) ............................................................................................................... 55
10.2 General ......................................................................................................................................... 55
10.2.1 Environmental conditions ...................................................................................................... 56
10.3 Option codes ................................................................................................................................. 56
10.4 Display.......................................................................................................................................... 56
10.4.1 Slave display......................................................................................................................... 56
10.4.2 Trends................................................................................................................................... 57
10.4.3 Alarms .................................................................................................................................. 57
10.5 Light Monitor battery module (optional) (w/2 battery slots) .............................................................. 57
10.6 Light Monitor backup battery (optional)........................................................................................... 57

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10.7 External power adapter................................................................................................................... 57
10.8 Light External Battery Charger (optional).......................................................................................... 58
10.9 Output specifications ..................................................................................................................... 58
10.9.1 Nurse Call and Defibrillator Synchronization Signals................................................................ 58
APPENDICES 59
FUNCTIONAL CHECK form A-1
SERVICE CHECK form B-1
EMC Guidance C-1
TABLE OF FIGURES
Figure 1 S/5 Light Monitor with battery module and power adapter .....................................................................1
Figure 2 Main block diagram of Light Monitor, revision 03 .................................................................................14
Figure 3 General troubleshooting chart.............................................................................................................49

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v

Introduction
1 INTRODUCTION
The S/5 Light Monitor is a portable factory configurated compact monitor designed for stationary
and mobile indoor monitoring of a patient’s vital signs. The monitor is available in two
configurations; F-LM1 and F-LMP1. The difference between the configurations is illustrated in
table 1. Additionally, the monitor can be equipped with an optional recorder and battery module.
An external power adapter is provided for power supply. The Light Monitor has also data card
option and Ethernet interface which enables connecting the monitor to the network for remote
monitoring the patient and data collection.
ll
l
Figure 1 S/5 Light Monitor with battery module and power adapter
Table 1 Basic parameter configurations
Parameters
ECGR NIBP SpO2TEMP InvBP
F-LM1 •••1 1) -
F-LMP1 •••1 1) 2 1)
1) number of channels
Parameter explanations:
ECGR ECG and respiration
NIBP Non-invasive blood pressure
SpO2Pulse oximetry
TEMP Temperature
InvBP Invasive blood pressure
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The following factory configurable parameters and functions are available:
• N-LNET; Network option
• N-LDATA; DataCard option
• N- LDNET; Network and DataCard options
• N-LCM; Mainstream CO2option
To all monitors following options are available:
• N-LREC; Thermal printer
• N-LPOW; External power supply, input: 110/230 VAC
• F-LBAT; Battery Module w/ two batteries
• N-LCHGR; External battery charger w/ two batteries
• N-LBB; Rechargeable built-in backup battery
1.1 Notes to the reader
GE Healthcare reserves the right to make changes in product specifications without prior notice.
The information in this manual is believed to be accurate and reliable; however, the manufacturer
assumes no responsibility for its use.
GE Healthcare assumes no responsibility for the use or reliability of its software on equipment that
is not furnished by GE Healthcare.
1.2 About this manual
This technical reference manual is intended for service personnel who will perform service and
maintenance procedures on the Light Monitor.
This technical reference manual is divided into two parts:
• Part I contains a general description of the monitor and service procedures.
• Part II contains detailed descriptions of the component parts of the monitor.
1.3 Related documents
S/5 Light Monitor User's Reference Manual
The User’s Reference Manual provides detailed instructions and references for the operation and
configuration of the monitor. Everyday service, maintenance procedures and troubleshooting hints
are also included.
Patient Monitor Supplies and Accessories
The Patient Monitor Supplies and Accessories Catalogue provides information on all supplies and
accessories available for the monitor.

Introduction
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1.4 Installation
1.4.1 Choosing the location
The monitor can be placed on a flat surface or hung with the handle from the bed or wall rails. Make
sure that the surface or rail holds up to at least 10 kg/22 lb.
1.4.2 Warnings
WARNING The monitor or its components should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the monitor and its
components should be observed to verify normal operation in the configuration
in which it will be used.
When choosing the location, refer to the appendix C later in this document.

Datex-Ohmeda S/5 Light Monitor
1.5 Symbols
1.5.1 Symbols on equipment
Attention, consult accompanying documents.
on the rear panel
indicates the
warning:
Electric shock hazard. Do not open monitor frame. Refer servicing to qualified personnel.
Do not touch any part of monitor or patient connections during defibrillation procedure.
Disconnect power supply before servicing. Use only external power adapter N-LPOW.
on the rear panel dust
filter indicates the
reminder:
Check rear panel dust filter regularly, and clean at least once a month.
on the patient
connector panel
indicates the
cautions:
Use only the specified cables and accessories.
Ensure proper contact of the return electrode of the electrosurgery unit to your patient to
avoid possible burns at ECG electrode or other probe sites.
on the external power
adapter indicates the
cautions:
For continued protection against fire hazard, replace only with same type and rating of fuse.
Make sure voltage selector is set according to local voltage.
For indoor use only. For patient transport outdoors use the monitor in protective case and
battery powered.
Do not immerse in liquid or allow any liquid to enter the interior.
on the battery unit
indicates the
warnings and
cautions:
Do not put in fire.
Do not short-circuit any terminals.
Do not disassemble or mutilate.
Use only with Battery Module or External Battery Charger.
Discharge and charge batteries fully every 3 months or more often, if required, to restore full
capacity.
Sealed NiCd battery must be recycled or disposed of properly. Discharge before disposing.
on the CPU board
indicates the caution:
There is a lithium battery on the CPU board. Discard useless battery according to local
regulations.
on the CO2 sensor Do not immerse the sensor in liquids or autoclave it.
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Introduction
SpO2: Type BF (IEC-60601-1) protection against electrical shock, not defibrillation proof.
T1: Type CF (IEC-60601-1) protection against electrical shock, not defibrillation proof.
NIBP: Type BF (IEC-60601-1) defibrillator-proof protection against electrical shock.
ECG, P1, P2: Type CF (IEC-60601-1) defibrillator-proof protection against electrical shock.
Ni-Cd
Battery packs contain heavy metal cadmium (chemical symbol Cd) and, in case of
disposal, must be separated from other waste according to local regulations.
This symbol indicates that the waste of electrical and electronic equipment must not be
disposed as unsorted municipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for information concerning the
decommissioning of your equipment.
Ni-C
d
Battery packs contain Ni-Cd and they can be recycled.
Protective earth terminal
Input voltage
Output voltage
Power ON/STANDBY
Alternating current
Direct current
IPX-class:
IPX0
Degree of protection against harmful ingress of water as detailed in the IEC 60529:
– ordinary equipment
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Datex-Ohmeda S/5 Light Monitor
IPX1
IPX4
– vertically falling water drops shall have no harmful effects.
– splash proof
SN, S/N Serial number
Battery charging LEDs: LEDs will blink while batteries are being charged, and will stay
illuminated when batteries are fully charged and the monitor is connected to mains.
The monitor is connected to the network (optional).
The DataCard (option) is inserted. If symbol is blinking the card is faulty, or it is not
inserted properly.
A blinking heart next to the heart rate or pulse rate value indicates the beats detected
A lung next to the respiration rate value indicates that respiration rate is calculated from
the impedance respiration measurement.
Silence alarm indicator. When displayed on the upper left corner of the screen, indicates
that all the alarms are silenced. When in the menu or digit fields, indicates that the
alarm source has been turned off.
Ethernet connectors
Printer connector
Sample gas outlet
Do not immerse the sensor in liquids.
ESD warning symbol for electrostatic sensitive devices. Pins of connectors identified
with the ESD warning symbol should not be touched. Connections should not be made
to these connectors unless ESD precautionary procedures are used. See section ”2.2
ESD precautionary procedures“ in this Technical Reference Manual for details.
Symbol for non-ionizing electromagnetic radiation. Interference may occur in the vicinity
of equipment marked with this symbol.
1.5.2 Symbols on transport packaging
The contents of the transport package are fragile and have to be handled with care.
This symbol indicates the correct upright position of the transport package.
The transport package must be kept in a dry environment.
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Introduction
This symbol is to indicate the temperature limitations within which the transport package
should be kept and handled.
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2 SAFETY
2.1 Safety precautions
2.1.1 Warnings
WARNING Indicates situations in which the user or the patient may be in danger of injury
or death.
Explosion hazard
• Do not use the monitor in presence of flammable anesthetics.
Electrical shock hazard
• Use only hospital grade grounded electrical outlets and power cord. Grounding reliability
can only be achieved when the equipment is connected to a receptacle marked ‘hospital
grade’.
• Do not remove cover. Refer servicing to qualified service personnel.
• Avoid any conductive contact to the probes and sensors.
• Disconnect the monitor from the electrical outlet before cleaning. Let it dry completely
before reconnecting it to the electrical outlet.
• Do not autoclave any part of the monitor with steam or ethylene oxide. Do not immerse in
liquid or allow liquid to enter the interior of any part.
• Make sure that external equipment is hospital grade grounded before connecting it to the
monitor. Do not connect any external equipment to the monitor, except that specified by GE
Healthcare.
• When connecting external equipment to the monitor, make sure that the whole combination
complies with safety standard IEC 60601-1-1 for the medical electrical systems and with
the requirements of local authorities. Non-medical electrical equipment connected to the
monitor shall be supplied from an extra isolating transformer which has a protectively
earthed outlet.
• Do not leave loose any sensor cables connected to patient. Either connect them to the
monitor or detach them from the patient.
• Do not use the monitor, any parts thereof or any accessories, if they have become wet or
exposed to liquid.
• Where the integrity of the external protective conductor installation or arrangement is in
doubt, equipment shall be operated from its internal power source.

Safety
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Patient safety
• Always make sure that necessary alarm limits are set and operative when you start
monitoring.
• When the alarms are suppressed, observe the patient frequently.
• Connect only one patient to one monitor at a time.
• Constant attention by a qualified professional is needed whenever a patient is under
anesthesia or connected to a ventilator. Some equipment malfunctions may pass
unnoticed in spite of the monitor alarm.
• Do not use antistatic or electrically conductive breathing tubes. They may increase the risk
of burns when electrosurgery unit is utilized.
• Do not use the monitor during magnetic resonance imaging (MRI).
• ECG, Impedance Respiration, InvBP: Ensure proper contact of the return electrode of the
electrosurgery unit to your patient to avoid possible burns at sensor sites.
• ECG, Impedance Respiration, InvBP: Make sure that no part of the patient connections
touches any electrically conductive material including earth.
• Impedance Respiration: In obstructive apnea, thoracic movements and impedance
variations may continue.
• NIBP: The monitor sets the inflation pressure automatically according to the first
measurement. Reset the case to reset the inflation limit before measuring a new patient.
• PATIENTS WITH PACEMAKERS OR ARRHYTHMIAS: Monitor may count the pacemaker pulses
as heart beats during cardiac arrest, some arrhythmias, and with certain types of
pacemakers particularly in ON R mode. Do not rely entirely upon rate meter alarms. Keep
patients with pacemakers and arrhythmias under close surveillance.
• PACEMAKER PATIENTS: The impedance respiration measurement may cause rate changes
in Minute Ventilation Rate Responsive Pacemakers. Set the pacemaker rate responsive
mode off or turn off the impedance respiration measurement on the monitor.
• SpO2: A damaged sensor, or a sensor soaked in liquid, may cause burns during
electrosurgery.
• SpO2: Change measuring site frequently. Change sensor site and check skin and circulatory
status every 2-4 hours with adults, and every hour with small children.
• The output signals are not floating and they must not be connected directly to a patient.
• Do not use delayed analog signals for defibrillator or intra-aortic balloon bump
synchronization.
• The monitor is intended for use by qualified medical personnel only.
• InvBP: All invasive procedures involve risks to the patient. Use aseptic technique. Follow
catheter manufacturer’s instructions.
• InvBP: Use only defibrillator proof cables and transducers.
• Operation of the monitor outside the specified values may cause inaccurate results.
• The monitor or its components should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the monitor and its components should
be observed to verify normal operation in the configuration in which it will be used.

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WARNING Use only approved accessories, mounts and defibrillator-proof cables and
invasive pressure transducers. For a list of approved supplies and accessories,
see the Supplies and Accessories catalog. Other cables, transducers and
accessories may cause a safety hazard, damage the equipment or system,
result in increased emissions or decreased immunity of the equipment or
system or interfere with the measurement. Protection against cardiac
defibrillator discharge is due in part to the accessories for pulse oximetry
(SpO2), temperature (T) and invasive pressure (P) measurement.
Single-use accessories are not designed to be re-used. Re-use may cause a risk
of contamination and affect the measurement accuracy.
Service
• Only trained personnel with proper tools and test equipment should perform the tests and
repairs described in this manual. Unauthorized service may void the monitor warranty.
• Switch the power off, unplug the power cord, and remove the batteries before service.
• The monitor is always energized with 12 V when the batteries are connected, even though
the power cord is removed and ON/STBY switch is in STBY position.
• Do not touch any exposed wire or conductive surface while covers are off and the monitor is
energized. The voltages present can cause injury or death.
• Electrostatic discharge through the PC boards may damage the components. Before
replacing PC boards, wear a static control wrist strap. Handle all PC boards by their non-
conductive edges and use anti static containers when transporting them.
• Do not break or bypass the patient isolation barrier when testing LM-STP and LM-ECG
boards.
• Do not perform any testing or maintenance on the monitor while they are being used on a
patient.
• There are special components used in this monitor, which are vital to assure reliability and
safety. GE Healthcare assumes no responsibility for damage if replacement components
not approved by GE Healthcare are used.
• Replace the fuse with a fuse of the same type and the same rating.
• Perform electrical safety checks and current leakage tests to the monitor after service.

Safety
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2.1.2 Cautions
CAUTION Indicates situations in which the unit or devices connected to it may be
damaged.
• Use licensed patient cables and accessories only, see Datex-Ohmeda Catalogue Patient
Monitor Supplies and Accessories. Other cables and accessories may damage the system
or interfere with measurement.
• Before connecting power cord, ensure that the input voltage selector is set correctly in the
external power adapter.
• Use the monitor outdoors with the battery power only.
• Do not store the monitor beyond the specified temperature range.
• Do not use hypochlorite, ammonia-, phenol- or acetone-based cleaners. They may damage
the monitor.
• Clean rear panel fan dust filter once a month or whenever needed.
• Leave space around the monitor for ventilation to prevent the monitor from overheating.
• Do not apply pressurized air to any outlet, or tubing connected to the monitor. Pressure may
destroy sensitive elements.
• When used in moving vehicle mount the monitor properly.
• Dispose of the device and parts thereof in accordance with local regulations.
• Vibrations during transport may disturb SpO2, ECG, impedance respiration and NIBP
measurements.
• CO2, SpO2: Do not apply force to sensors or sensor cables.
• CO2: Do not force the water-trap into place.
• DataCards: Do not subject cards to excessive heat, bending, or magnetic fields.
• InvBP: Mechanical shock to invasive blood pressure transducer may cause severe shifts in
zero balance and calibration, and produce erroneous readings.
• Electromagnetic interference from radio-frequency transmitting devices in ambulances may
affect the performance of this medical device.
Battery cautions
• Do not put in fire.
• Do not short-circuit any terminals.
• Do not use damaged or leaking batteries.
• Do not disassemble or break the batteries.
• Use only with Battery Module.
• Charge and discharge batteries fully every 3 months or more often, if required, to restore full
capacity.
• Sealed NiCd battery must be recycled or disposed properly. Discharge before disposing.

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Storage and transport
• For allowed storage and transport conditions refer to the documentation delivered with the monitor.
Points to note
• Medical electrical equipment needs special precautions regarding electromagnetic compatibility and
needs to be installed and put into service by qualified personnel according to the electromagnetic
compatibility information provided in the Appendix C.
• Portable and mobile RF communications equipment can affect the medical electrical equipment.
• The allowed cables, transducers and accessories for the system are listed in the Supplies and
Accessories catalog delivered with the monitor.
• The equipment is suitable for use in the presence of electrosurgery. Please notice the possible
limitations in the parameter sections and in the "Safety precautions" section.
• Service and reparations are allowed for authorized service personnel only.
• CISPR 11 classifications:
− Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is
intentionally generated and/or used conductively coupled radio-frequency energy which is
necessary for the internal functioning of the equipment itself.
− Class A equipment is suitable for use in all establishments other than domestic and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic
purposes.
2.2 ESD precautionary procedures
• To avoid electrostatic charges to build up, it is recommended to store, maintain and use the
equipment at a relative humidity of 30% or greater. Floors should be covered by ESD
dissipative carpets or similar. Non-synthetic clothing should be used when working with the
component.
• To prevent applying a possible electrostatic discharge to the ESD sensitive parts of the
equipment, one should touch the metallic frame of the component or a large metal object
located close to the equipment. When working with the equipment and specifically when the
ESD sensitive parts of the equipment may be touched, a grounded wrist strap intended for use
with ESD sensitive equipment should be worn. Refer to the documentation provided with the
wrist straps for details of proper use.
ESD precautionary procedure training
It is recommended that all potential users receive an explanation of the ESD warning symbol and
training in ESD precautionary procedures.
The minimum contents of ESD precautionary procedure training should include an introduction to
the physics of electrostatic charge, the voltage levels that can occur in normal practice and the
damage that can be done to electronic components if they are touched by an operator who is
electrostatically charged. Further, an explanation should be given of methods to prevent build-up of
electrostatic charge and how and why to discharge one’s body to earth or to the frame of the
equipment or bond oneself by means of a wrist strap to the equipment or the earth prior to making
a connection.